Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162981
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2005-09-09
Brief Title:
Clobazam in Subjects With Lennox-Gastaut Syndrome
Sponsor:
Lundbeck LLC
Organization:
Lundbeck LLC
Study Overview
Official Title:
Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks drop seizures in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome LGS Subjects will be enrolled at approximately 10 investigational sites in the US for up to 15 weeks Subjects will be randomly assigned to either a low dose or a high dose The study will include a baseline period a titration period and a maintenance period After the maintenance period subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose
Detailed Description:
LGS poses a significant treatment challenge While antiepileptic medications are the mainstay of treatment no one antiepileptic drug AED provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required Many patients with LGS are refractory to standard AED treatment
More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients Clobazam is unique in that it is the only non-1 4-benzodiazepine used in the treatment of epilepsy
More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients Clobazam is unique in that it is the only non-1 4-benzodiazepine used in the treatment of epilepsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OV1002 | OTHER | Former study ID | None |